Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-25 @ 2:34 PM
Study NCT ID:
NCT00161850
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004675', 'term': 'Encephalitis, Tick-Borne'}], 'ancestors': [{'id': 'D004671', 'term': 'Encephalitis, Arbovirus'}, {'id': 'D018792', 'term': 'Encephalitis, Viral'}, {'id': 'D020805', 'term': 'Central Nervous System Viral Diseases'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000069544', 'term': 'Infectious Encephalitis'}, {'id': 'D001102', 'term': 'Arbovirus Infections'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}, {'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D018177', 'term': 'Flavivirus Infections'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D004660', 'term': 'Encephalitis'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 615}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2002-08'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Encephalitis, Tick-borne']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and immunogenicity of the third vaccination with one of three different concentrations of a TBE vaccine in all subjects who completed two vaccinations in one of the three treatment groups of Baxter study 199 (a dose-finding study to investigate the safety and immunogenicity of two vaccinations with FSME IMMUN NEW in healthy subjects aged 1 to 6 years).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Year', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll volunteers who participated in Baxter study 199 and received two vaccinations will be invited to participate. Male and female children will be eligible for participation in this study if:\n\n* They received two vaccinations with one of the three different dosages of FSME IMMUN NEW during the course of Baxter study 199\n* Written informed consent from the legal guardian is available.\n\nExclusion Criteria:\n\nThere are no specific exclusion criteria for this study entry. However volunteers will be assessed for eligibility to receive a third vaccination.\n\nVolunteers will be excluded from vaccination and consecutive visits in this study if they:\n\n* Are not clinically healthy, (i. e. the physician would have reservations vaccinating with FSME IMMUN NEW outside the scope of a clinical trial)\n* Have already been administered a third TBE vaccination elsewhere after the two vaccinations in Baxter study 199\n* Have had an allergic reaction to one of the components of the vaccine since the last vaccination in Baxter study 199\n* Suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment (e.g. systemic corticosteroids, chemotherapeutics) that can be expected to influence immunological functions\n* Have received banked human blood or immunoglobulins within one month of study entry\n* Are known to be HIV positive (a special HIV test is not required for the purpose of the study) since the last visit of Baxter study 199\n* Have had a vaccination against yellow fever and / or Japanese B-encephalitis since the last visit in Baxter study 199\n* Had received an investigational new drug within 6 weeks prior to study start'}, 'identificationModule': {'nctId': 'NCT00161850', 'briefTitle': 'FSME IMMUN NEW Follow-up to Study 199 in Children Aged 1 to 6 Years', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Follow-up Study to Investigate the Safety and Immunogenicity of a Third Vaccination With Three Different Antigen Concentrations of FSME IMMUN NEW in Children Aged 1 to 6 Years', 'orgStudyIdInfo': {'id': '206'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'A-4600', 'city': 'Wels', 'country': 'Austria', 'facility': 'Grieskirchner Strasse 17', 'geoPoint': {'lat': 48.16667, 'lon': 14.03333}}, {'zip': 'D-86163', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Neuschwanstein Strasse 5', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': 'D-88348', 'city': 'Bad Saulgau', 'country': 'Germany', 'facility': 'Marktplatz 33', 'geoPoint': {'lat': 48.01676, 'lon': 9.50064}}, {'zip': 'D-74321', 'city': 'Bietigheim-Bissingen', 'country': 'Germany', 'facility': 'Hauptstrasse 9', 'geoPoint': {'lat': 48.94407, 'lon': 9.11755}}, {'zip': 'D-75365', 'city': 'Calw', 'country': 'Germany', 'facility': 'Salzgasse 11', 'geoPoint': {'lat': 48.71419, 'lon': 8.74031}}, {'zip': 'D-96450', 'city': 'Coburg', 'country': 'Germany', 'facility': 'Mohrenstrasse 8', 'geoPoint': {'lat': 50.25937, 'lon': 10.96384}}, {'zip': 'D-79215', 'city': 'Elzach', 'country': 'Germany', 'facility': 'Bahnhofstrasse 1', 'geoPoint': {'lat': 48.17247, 'lon': 8.06992}}, {'zip': 'D-77955', 'city': 'Ettenheim', 'country': 'Germany', 'facility': 'Rheinstrasse 1a', 'geoPoint': {'lat': 48.25696, 'lon': 7.81247}}, {'zip': 'D-88046', 'city': 'Friedrichshafen', 'country': 'Germany', 'facility': 'Ehlerstrasse 17', 'geoPoint': {'lat': 47.65689, 'lon': 9.47554}}, {'zip': 'D-36129', 'city': 'Gersfeld', 'country': 'Germany', 'facility': 'Peter-Seifert Strasse 5', 'geoPoint': {'lat': 50.45138, 'lon': 9.91422}}, {'zip': 'D-74072', 'city': 'Heilbronn', 'country': 'Germany', 'facility': 'Solothumer Strasse 2', 'geoPoint': {'lat': 49.13995, 'lon': 9.22054}}, {'zip': 'D-77694', 'city': 'Kehl', 'country': 'Germany', 'facility': 'Hauptstrasse 240', 'geoPoint': {'lat': 48.57297, 'lon': 7.81523}}, {'zip': 'D-79199', 'city': 'Kirchzarten', 'country': 'Germany', 'facility': 'Schwarzwald Strasse 20', 'geoPoint': {'lat': 47.96667, 'lon': 7.95}}, {'zip': 'D-86899', 'city': 'Landsberg', 'country': 'Germany', 'facility': 'Altoettinger Strasse 3', 'geoPoint': {'lat': 51.52698, 'lon': 12.16076}}, {'zip': '68239', 'city': 'Mannheim-Secken', 'country': 'Germany', 'facility': 'Rastatter Strasse 7'}, {'zip': 'D-72555', 'city': 'Metzingen', 'country': 'Germany', 'facility': 'Wilhelmstrasse 25', 'geoPoint': {'lat': 48.53695, 'lon': 9.2833}}, {'zip': 'D-90449', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Dohmbuehler Strasse 8', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': 'D-90473', 'city': 'Nuremberg', 'country': 'Germany', 'facility': 'Glogauer Strasse 15', 'geoPoint': {'lat': 49.45421, 'lon': 11.07752}}, {'zip': 'D-78727', 'city': 'Oberndorf/Neckar', 'country': 'Germany', 'facility': 'Tuchbergstrasse 2'}, {'zip': 'D-77654', 'city': 'Offenburg', 'country': 'Germany', 'facility': 'Wilhelmstrasse 7', 'geoPoint': {'lat': 48.47377, 'lon': 7.94495}}, {'zip': 'D-77656', 'city': 'Offenburg', 'country': 'Germany', 'facility': 'Asternweg 11a', 'geoPoint': {'lat': 48.47377, 'lon': 7.94495}}, {'zip': 'D-78628', 'city': 'Rottweil', 'country': 'Germany', 'facility': 'Bergstrasse 27', 'geoPoint': {'lat': 48.16783, 'lon': 8.62719}}, {'zip': 'D-78713', 'city': 'Schramberg', 'country': 'Germany', 'facility': 'Berneckstrasse 19', 'geoPoint': {'lat': 48.22399, 'lon': 8.38583}}, {'zip': 'D-83681', 'city': 'Tegernsee', 'country': 'Germany', 'facility': 'Hauptstrasse 11', 'geoPoint': {'lat': 47.7123, 'lon': 11.7582}}, {'zip': 'D-88250', 'city': 'Weingarten', 'country': 'Germany', 'facility': 'Broner Platz 6', 'geoPoint': {'lat': 47.81009, 'lon': 9.63863}}], 'overallOfficials': [{'name': 'Baxter BioScience Investigator', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baxter Healthcare Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}}}}